2103 Patent Examination Process [R-08.2017]

I. DETERMINE WHAT APPLICANT HAS INVENTED AND IS SEEKING TO PATENT

It is essential that patent applicants obtain a prompt
yet complete examination of their applications. Under the principles of compact
prosecution, each claim should be reviewed for compliance with every statutory
requirement for patentability in the initial review of the application, even if one or
more claims are found to be deficient with respect to some statutory requirement. Thus,
examiners should state all reasons and bases for rejecting claims in the first Office
action. Deficiencies should be explained clearly, particularly when they serve as a
basis for a rejection. Whenever practicable, examiners should indicate how rejections
may be overcome and how problems may be resolved. A failure to follow this approach can
lead to unnecessary delays in the prosecution of the application.

Prior to focusing on specific statutory requirements,
examiners must begin examination by determining what, precisely, the applicant has
invented and is seeking to patent, and how the claims relate to and define that
invention. Examiners will review the complete specification, including the detailed
description of the invention, any specific embodiments that have been disclosed, the
claims and any specific, substantial, and credible utilities that have been asserted for
the invention.

After obtaining an understanding of what applicant
invented, the examiner will conduct a search of the prior art and determine whether the
invention as claimed complies with all statutory requirements.

A. Identify and Understand Any Utility for the Invention

The claimed invention as a whole must be useful. The
purpose of this requirement is to limit patent protection to inventions that possess
a certain level of “real world” value, as opposed to subject matter that represents
nothing more than an idea or concept, or is simply a starting point for future
investigation or research (Brenner v. Manson, 383 U.S. 519,
528-36, 148 USPQ 689, 693-96 (1966); In re Fisher, 421 F.3d 1365,
76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197,
1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)).

Examiners should review the application to identify any
asserted utility. The applicant is in the best position to explain why an invention
is believed useful. Accordingly, a complete disclosure should contain some indication
of the practical application for the claimed invention, i.e., why the applicant
believes the claimed invention is useful. Such a statement will usually explain the
purpose of the invention or how the invention may be used (e.g., a compound is
believed to be useful in the treatment of a particular disorder). Regardless of the
form of statement of utility, it must enable one ordinarily skilled in the art to
understand why the applicant believes the claimed invention is useful. See
MPEP §
2107 for utility examination guidelines. An applicant may
assert more than one utility and practical application, but only one is necessary.
Alternatively, an applicant may rely on the contemporaneous art to provide that the
claimed invention has a well-established utility.

B. Review the Detailed Disclosure and Specific Embodiments of the Invention
To Understand What the Applicant Has Invented

The written description will provide the clearest
explanation of the applicant’s invention, by exemplifying the invention, explaining
how it relates to the prior art and explaining the relative significance of various
features of the invention. Accordingly, examiners should continue their evaluation
by

(A) determining the function of the invention,
that is, what the invention does when used as disclosed (e.g., the
functionality of a programmed computer); and

(B) determining the features necessary to
accomplish at least one asserted practical application.

Patent applicants can assist the USPTO by preparing
applications that clearly set forth these aspects of an invention.

C. Review the Claims

The claims define the property rights provided by a
patent, and thus require careful scrutiny. The goal of claim analysis is to identify
the boundaries of the protection sought by the applicant and to understand how the
claims relate to and define what the applicant has indicated is the invention.
Examiners must first determine the scope of a claim by thoroughly analyzing the
language of the claim before determining if the claim complies with each statutory
requirement for patentability. See In re Hiniker Co., 150 F.3d
1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998) (“[T]he name of the game is the
claim.”).

Examiners should begin claim analysis by identifying
and evaluating each claim limitation. For processes, the claim limitations will
define steps or acts to be performed. For products, the claim limitations will define
discrete physical structures or materials. Product claims are claims that are
directed to either machines, manufactures or compositions of matter.

Examiners should then correlate each claim limitation
to all portions of the disclosure that describe the claim limitation. This is to be
done in all cases, regardless of whether the claimed invention is defined using
means- (or step-) plus- function language. The correlation step will ensure that
examiners correctly interpret each claim limitation in light of the specification.

The subject matter of a properly construed claim is
defined by the terms that limit the scope of the claim when given their broadest
reasonable interpretation. It is this subject matter that must be examined. As a
general matter, grammar and the plain meaning of terms as understood by one having
ordinary skill in the art used in a claim will dictate whether, and to what extent,
the language limits the claim scope. See MPEP § 2111.01 for more information
on the plain meaning of claim language. Language that suggests or makes a feature or
step optional but does not require that feature or step does not limit the scope of a
claim under the broadest reasonable claim interpretation. The following types of
claim language may raise a question as to its limiting effect:

(A) statements of intended use or field of use,
including statements of purpose or intended use in the preamble,

(B) “adapted to” or “adapted for” clauses,

(C) "wherein" or "whereby" clauses,

(D) contingent limitations,

(E) printed matter, or

(F) terms with associated functional
language.

This list of examples is not intended to be exhaustive.
The determination of whether particular language is a limitation in a claim depends
on the specific facts of the case. See, e.g., Griffin v. Bertina,
285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002)(finding that a “wherein” clause
limited a process claim where the clause gave “meaning and purpose to the
manipulative steps”). For more information about these types of claim language and
how to determine whether they have a limiting effect on claim scope, see
MPEP §§
2111.02 through
2111.05.

Examiners are to give claims their broadest
reasonable interpretation in light of the supporting disclosure. See
MPEP §
2111. Disclosure may be express, implicit, or inherent.
Examiners are to give claimed means- (or step-) plus- function limitations their
broadest reasonable interpretation consistent with all corresponding structures (or
materials or acts) described in the specification and their equivalents. See
In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (fed.
Cir. 2011). Further guidance in interpreting the scope of equivalents is provided in
MPEP §§
2181 through 2186.

While it is appropriate to use the specification to
determine what applicant intends a term to mean, a positive limitation from the
specification cannot be read into a claim that does not itself impose that
limitation. See MPEP §
2111.01, subsection II. As explained in
MPEP §
2111, giving a claim its broadest reasonable interpretation
during prosecution will reduce the possibility that the claim, when issued, will be
interpreted more broadly than is justified.

Finally, when evaluating the scope of a claim, every
limitation in the claim must be considered. Examiners may not dissect a claimed
invention into discrete elements and then evaluate the elements in isolation.
Instead, the claim as a whole must be considered. See, e.g., Diamond v.
Diehr, 450 U.S. 175, 188-89, 209 USPQ 1, 9 (1981) (“In determining the
eligibility of respondents’ claimed process for patent protection under
§
101, their claims must be considered as a whole. It is
inappropriate to dissect the claims into old and new elements and then to ignore the
presence of the old elements in the analysis. This is particularly true in a process
claim because a new combination of steps in a process may be patentable even though
all the constituents of the combination were well known and in common use before the
combination was made.”).

II. CONDUCT A THOROUGH SEARCH OF THE PRIOR ART

Prior to evaluating the claimed invention for
patentability, examiners are expected to conduct a thorough search of the prior art. See
MPEP §§
904 through 904.03 for more information about how
to conduct a search. In many cases, the result of such a search will contribute to
examiners understanding of the invention. Both claimed and unclaimed aspects of the
invention described in the specification should be searched if there is a reasonable
expectation that the unclaimed aspects may be later claimed. A search must take into
account any structure or material described in the specification and its equivalents
which correspond to the claimed means- (or step-) plus- function limitation, in
accordance with 35 U.S.C. 112(f) and
MPEP §
2181 through MPEP § 2186.

Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title.

35 U.S.C.
101 has been interpreted as imposing four requirements: (i)
only one patent may be obtained for an invention; (ii) the inventor(s) must be
identified in an application filed on or after September 16, 2012 or must be the
applicant in applications filed before September 16, 2012; (iii) the claimed
invention must be eligible for patenting; and, (iv) the claimed invention must be
useful.

The patent eligibility inquiry under 35 U.S.C. 101
is a threshold inquiry. Even if a claimed invention qualifies as eligible subject
matter under 35
U.S.C. 101, it must also satisfy the other conditions and
requirements of the patent laws, including the requirements for novelty
(35 U.S.C.
102), nonobviousness (35 U.S.C. 103), and adequate
description and definite claiming (35 U.S.C. 112). Bilski
v. Kappos, 561 U.S. 593, 602, 95 USPQ2d 1001, 1006 (2010). Therefore,
examiners should avoid focusing on issues of patent-eligibility under
35 U.S.C.
101 to the detriment of considering an application for
compliance with the requirements of 35 U.S.C. 102, 35 U.S.C. 103,
and 35 U.S.C.
112, and should avoid treating an application solely on the
basis of patent-eligibility under 35 U.S.C. 101 except in the most
extreme cases.

35 U.S.C.
112(b) contains two separate and distinct requirements: (A)
that the claim(s) set forth the subject matter applicants regard as the invention,
and (B) that the claim(s) particularly point out and distinctly claim the invention.
An application will be deficient under the first requirement of 35 U.S.C.
112(b) when evidence including admissions, other than in the
application as filed, shows that an applicant has stated what they regard the
invention to be is different from what is claimed (see MPEP § 2171 -
MPEP §
2172.01).

An application fails to comply with the second
requirement of 35 U.S.C. 112(b) when the claims
do not set out and define the invention with a reasonable degree of precision and
particularity. In this regard, the definiteness of the language must be analyzed, not
in a vacuum, but always in light of the teachings of the disclosure as it would be
interpreted by one of ordinary skill in the art. Applicant’s claims, interpreted in
light of the disclosure, must reasonably apprise a person of ordinary skill in the
art of the invention.

The scope of a limitation that invokes
35
U.S.C. 112(f) is defined as the corresponding structure or
material set forth by the inventor in the written description and equivalents thereof
that perform the claimed function. See MPEP § 2181 through
MPEP §
2186. See MPEP § 2173et seq. for a discussion of a variety of issues pertaining to the
35
U.S.C. 112(b) requirement that the claims particularly point
out and distinctly claim the invention.

For the written description requirement, an
applicant’s specification must reasonably convey to those skilled in the art that
the applicant was in possession of the claimed invention as of the date of
invention. See MPEP
§ 2163 for further guidance with respect to the
evaluation of a patent application for compliance with the written description
requirement.

2. Enabling Disclosure

An applicant’s specification must enable a person
skilled in the art to make and use the claimed invention without undue
experimentation. The fact that experimentation is complex, however, will not make
it undue if a person of skill in the art typically engages in such complex
experimentation.

Determining compliance with the best mode
requirement requires a two-prong inquiry:

(1) at the time the application was filed, did
the inventor possess a best mode for practicing the invention; and

(2) if the inventor did possess a best mode,
does the written description disclose the best mode such that a person
skilled in the art could practice it.

See MPEP § 2165et seq. for additional guidance. Deficiencies related to
disclosure of the best mode for carrying out the claimed invention are not usually
encountered during examination of an application because evidence to support such
a deficiency is seldom in the record. Fonar Corp. v. General Elec.
Co., 107 F.3d 1543, 1548-49, 41 USPQ2d at 1804-05.

Reviewing a claimed invention for compliance with
35 U.S.C.
102 and 35 U.S.C.103 begins with a
comparison of the claimed subject matter to what is known in the prior art. See
MPEP §§
2131 - 2146 and MPEP §§
2150 - 2159 for specific guidance on
patentability determinations under 35 U.S.C. 102 and 35 U.S.C. 103. If
no differences are found between the claimed invention and the prior art, then the
claimed invention lacks novelty and is to be rejected by USPTO personnel under
35 U.S.C.
102. Once differences are identified between the claimed invention
and the prior art, those differences must be assessed and resolved in light of the
knowledge possessed by a person of ordinary skill in the art. Against this backdrop, one
must determine whether the invention would have been obvious to one of ordinary skill in
the art. If not, the claimed invention satisfies 35 U.S.C. 103.

VI. CLEARLY COMMUNICATE FINDINGS, CONCLUSIONS AND THEIR BASES

Once examiners have concluded the above analyses of the
claimed invention under all the statutory provisions, including 35 U.S.C. 101,
35 U.S.C.
112, 35 U.S.C. 102, and 35 U.S.C. 103,
they should review all the proposed rejections and their bases to confirm that they are
able to set forth a prima facie case of unpatentability. Only then
should any rejection be imposed in an Office action. The Office action should clearly
communicate the findings, conclusions and reasons which support them.